• The FDA has approved Gemtesa (vibegron) for men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia (BPH).
• Gemtesa is the first and only beta-3 adrenergic receptor agonist approved for OAB in men being treated for BPH, addressing a significant unmet need.
• Approval was based on a Phase 3 trial demonstrating significant reductions in micturition and urgency episodes compared to placebo.
• Common adverse reactions in the trial included hypertension and urinary tract infections, with a similar rate of serious adverse events to placebo.